ANZCTR search results

Gender affirming hormone therapy is used by many transgender (trans) individuals and results in considerable changes in sex hormone levels (testosterone and estrogen). These hormonal changes affect skeletal muscle mass, but the underlying effects on physiological measures, such as aerobic fitness and muscle strength, as well as molecular markers such as epigenetics are unclear. Given the use of gender affirming hormone therapy by trans individuals is rising, it is critical that we further examine the short and long-term impacts of these therapies, with potential for research in this area to improve outcomes and personalise care for trans people and promote the fair inclusion of trans communities into sports commonly separated by gender. The aim of this project is to further understand the effects of gender affirming hormone therapy on physiological and molecular measures of skeletal muscle health and function. This study will include transgender participants commencing gender affirming hormone treatment, as well as of cisgender participants not undergoing any treatment, with all participants followed up over 12 months. The study involves participants undertaking aerobic and strength fitness tests and body composition scans and providing de-identified blood and muscle samples for analyses. Multiple outcomes will be assessed over 12 months, including changes in fitness tests, body composition, and epigenetic and blood markers such as DNA methylation and blood glucose. Outcomes will be compared before and after 6 and 12 months of hormone therapy in transgender individuals, and compared to outcomes in cisgender individuals, allowing us to assess the effects of gender affirming hormone treatments in depth.

Following the closure of an enterostomy, post-operative fasting for a few days has been the norm, however, this prolonged fasting may not be necessary. Thus, we are planning a randomised control trial that compares the efficacy of early feeding with feeding after post-operative fasting in paediatric patients undertaking elective enterostomy closure. The hypothesis is that early feeding leads to shorter length of hospital stay, reduced pain, reduced rate of surgical complications and improved parent/carer satisfaction at discharge from hospital.

The aim of this study is to evaluate safety and tolerability of SVT-4A1011 as a treatment for Insomnia together with preliminary efficacy. The treatment consists of selected bacterial species that are naturally found in the digestive tract. They are a research focus for their important role in many conditions related to gut health. Bacteria play an important role in the function of the immune system, digestive health, inflammation and gut/brain axis. Several research studies have identified certain gut bacteria having direct interaction and regulation of key neurotransmitters and pathways associated with sleep including influencing the host circadian rhythm. This study will help determine how safe and effective SVT-4A1011 is as a stand-alone therapy in treating Clinically Diagnosed Insomnia. The hypothesis of this study is that, twice daily consumption of the study drug SVT-4A1011 will result in improved quality of sleep in individuals with clinically diagnosed insomnia.

The RIVASTIM trials aim to identify strategies to improve immunological responses to a 3rd booster dose of the mRNA Pfizer Comirnaty COVID-19 vaccine in a cohort of kidney transplant patients who have failed to achieve an adequate immune response to a standard two-dose COVID-19 vaccine course. Kidney transplant patients are a highly vulnerable group of immunosuppressed patients who suffer from disproportionately high COVID-19-related morbidity and mortality. The transplant medication sirolimus shows promise in enhancing immune responses to COVID-19 vaccination. In this study kidney transplant patients receiving standard of care immunosuppression with tacrolimus, mycophenolate, and steroids will be randomised to either switch from mycophenolate to sirolimus, or remain on standard of care immunosuppression. Four weeks after randomisation, participants will receive a 3rd COVID-19 vaccine dose, and immunological responses will be assessed 4-6 weeks later.

The study is evaluating the feasibility of hyper-accelerated partial breast irradiation therapy in women with breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above who has been diagnosed with invasive non-lobular breast carcinoma and have had breast conserving surgery. Trial details: All participants in this study will undergo a procedure called hyper-accelerated partial breast irradiation. This involves catheters implantation under general anaesthetic followed by three treatment doses of brachytherapy radiation. All participants will be followed up for a maximum of 10 years to assess for recurrences and quality of life, which will involve performing annual mammogram scan and completing questionnaires (6 weeks, 6 months and annually for 5 years). A peripheral blood sample and the resected tumour sample will also be assessed at the time of commencing therapy (and then 6 weeks,1 year, 5 year and 10 year) to identify potential biomarkers of local disease recurrence. It is hoped that this study may show that hyper-accelerated partial breast irradiation therapy is feasible, safe, and efficacious for the treatment of locally advanced breast cancer. It may also help to identify biomarkers to allow for accurate selection of patients who are suitable for this treatment in future.

Inflammation is a key component in the cause of ischemic stroke. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever, and acute/recurrent pericarditis. There is an increasing body of evidence in the literature supporting a beneficial role of long-term colchicine therapy in prevention of cardiovascular disease. Low-dose colchicine use has also been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this trial is to assess the effect of low-dose colchicine (0.5mg/daily) in addition to optimal medical therapy of cardiovascular outcomes in stroke patients with evidence of persistent coronary inflammation (based on hs-CRP). We hypothesise that addition of colchicine to optimal medical therapy in patients post-stroke, who have biomarker evidence of persistent inflammation will reduce recurrent cardiovascular events.

Cardiovascular disease (CVD) is the main cause of death in women. Current ways to check for CVD in women are unreliable. Breast artery calcification (BAC) is build-up of calcium in the blood vessels of the breast. It can be seen on mammograms and is related to CVD. The way in which CVD develops and progresses is not clear. A cardiac CT scan is a specialised X-ray test that allows you to look at the arteries of the heart. Using a computer software we can measure the plaque which blocks arteries, some of which are 'high risk plaque' meaning they are associated with future heart attacks. We can also measure other markers such as peri-coronary adipose tissue which is indicative of inflammation that can predict the development of plaque. In this study we will recruit patients with previous mammogram and a cardiac CT to have another cardiac CT to look at the change in plaque and compare BAC to no BAC. This will allow us to examine the association of BAC with coronary plaque presence and progression. We expect that patients with BAC will have more plaque, inflammation and high risk plaque on their previously conducted clinical cardiac CT. We also expect patients with BAC to show greater progression of these parameters on their research cardiac CT when compared to their previously conducted clinical cardiac CT.

Seaweeds comprise a diverse range of marine organisms containing biologically active metabolites that are being explored for their therapeutic effect(s) on a range of health conditions. This project provides a novel opportunity to assess the role of inflammatory processes and the microbiome in the oesophagus in Eosinophilic oesophagitis (EoE). The aim of this study is to examine the clinical effectiveness of fucoidan supplementation in alleviating symptoms of Eosinophilic oesophagitis(EoE). To better understand the local immune pathways and responsiveness to supplementation oesophageal biopsy samples will be used to characterise immune and inflammatory signalling and to assess microbiome composition at the mucosal oesophageal surface.

This is a observational prospective cohort study whereby convenient and routine venous bloods are collected prior to commencement (day 2 menses) IVF or ICSI, antagonist treatment and oocyte collection, and analysed for proteomic biomarkers indicative of embryo quality score and clinical pregnancy. The primary objective is to develop a predictive model that facilitates decision-making in the clinic, particularly regarding the choice to proceed to oocyte collection given the subject’s health status and probability of assisted reproduction success.

The aim of this study is to determine whether it is feasible to conduct a study of crushed oral dexamethasone, at a dose of at least 8 mg daily, either with or without daily crushed oral famotidine in the management of inoperable bowel obstruction. Who is it for? You may be eligible for this study if you are aged 18 years or older, have advanced cancer, and have a clinically confirmed inoperable bowel obstruction at any level with vomiting that requires a hospital admission or a change in clinical care. Study details Participants will be randomised (i.e. allocated by chance) to receive 5 days of either 40mg per day of famotidine or placebo as a crushed oral tablet. All participants will also receive a single daily dose of 8mg of dexamethasone for 5 days and intravenous or subcutaneous fluids at 10-20ml/kg/24 hours, as part of standard care. Participants will be assessed daily for the duration of treatment to monitor safety and tolerability, where the study team will visit each day and assess any side effects and improvement. Participants will also complete a number of questionnaires on the last day of treatment, as well as weekly for 4 weeks post-treatment completion. These questionnaires will involve answering questions regarding general well-being and quality of life, vomiting episodes, pain, nausea, side effects, medication use, and use of rescue pain medications. Analysis for cost-effectiveness of the intervention will also occur. It is hoped that this study will help clinicians to further understand the management of of inoperable malignant bowel obstruction.